Prescription drug · NDA
Desvenlafaxine NDC 63304-191
Desvenlafaxine 50 mg/1 · Tablet, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-191-30 | 6330401913063304019130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-30)Marketed from Mar 5, 2013 | |
| 63304-191-90 | 6330401919063304019190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-90)Marketed from Mar 5, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desvenlafaxine
- Generic name (nonproprietary)
- desvenlafaxine
- Active ingredients
- Desvenlafaxine — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204150
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 63304-191_cd04a0b2-a7f2-4629-997f-af2a8e65f15bSPL ID cd04a0b2-a7f2-4629-997f-af2a8e65f15bSPL set ID 91cf39c9-4d26-480a-a3a3-a3d8d4c4d222RxCUI 790264, 790288UNII NG99554ANW
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463304019130followed by a unit qualifier and the quantityPackage 63304-0191-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)] . Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).
Excerpt only. Read the full label for complete information.
About NDC 63304-191
- What is NDC 63304-191?
- 63304-191 is the product NDC for Desvenlafaxine, Desvenlafaxine 50 mg/1 tablet, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desvenlafaxine.
- What is the active ingredient?
- Desvenlafaxine.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desvenlafaxine?
- 52 other product NDCs are listed under this name. See all Desvenlafaxine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desvenlafaxine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-821 | 10135-0821-1010135-0821-1410135-0821-30+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-822 | 10135-0822-1010135-0822-1410135-0822-30+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-5332 | 68071-5332-03 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-555 | 72603-0555-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-556 | 72603-0556-0172603-0556-02 |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-557 | 72603-0557-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8760 | 68788-8760-0168788-8760-0368788-8760-06+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7190 | 50090-7190-0050090-7190-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7737 | 50090-7737-0050090-7737-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3790 | 68071-3790-03 |
Other NDCs under NDA 204150
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desvenlafaxine | Desvenlafaxine 50 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-152 |
| Desvenlafaxine | Desvenlafaxine 100 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-153 |
| Desvenlafaxine | Desvenlafaxine 100 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-192 |